Reported Aug 30, 2023 · Ongoing
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
BioFire Diagnostics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioFire Diagnostics, LLC · 515 S Colorow Dr · Salt Lake City, UT · 84108-1248
Is this the product you have?
- FilmArray Pneumonia Panel (Pneumo)
- REFRFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
- Lot codes and dates
- Pouch Lot # 2NBT22 /Kit # 2187822
- UDI-DIUDI: 00815381020482
- Amount recalled
- 24 Kits (30 pouches/kit)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Due to manufacturing issue, panels may result in false negative results.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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